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Trial record 1 of 1 for:    NCT00635752
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Trauma-focused Cognitive-behavioural Therapy(TF-CBT) for Children: A Study of Process and Outcome.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635752
First Posted: March 14, 2008
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norway: Directorate for Health and Social Affairs
Information provided by (Responsible Party):
Tine K. Jensen, Norwegian Center for Violence and Traumatic Stress Studies
  Purpose
The purpose of this study is to determine whether Trauma focused cognitive behavioral therapy (TF-CBT)is more effective in the treatment of traumatized youth than treatment as usual(TAU).

Condition Intervention
Post-Traumatic Stress Disorder Other: TF-CBT Other: Treatment as Usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trauma-focused Cognitive-behavioural Therapy for Children: A Study of Process and Outcome.

Resource links provided by NLM:


Further study details as provided by Tine K. Jensen, Norwegian Center for Violence and Traumatic Stress Studies:

Primary Outcome Measures:
  • PTSD [ Time Frame: Before session, middle, end, one year follow-up, 18 month follow-up ]

Secondary Outcome Measures:
  • Parent distress [ Time Frame: Before session, middle, end, one year follow-up, 18 month follow-up ]
  • Therapeutic alliance [ Time Frame: After 1st. and 6th. session ]

Enrollment: 156
Study Start Date: April 2008
Study Completion Date: August 2013
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive trauma-focused cognitive behavioral therapy (TF-CBT)
Other: TF-CBT
TF-CBT sessions will include trauma-focused treatment, and will teach participants behavioral and coping skills.
Active Comparator: 2
Participants will receive sessions of treatment as usual (TAU)
Other: Treatment as Usual (TAU)
Participants will receive regular therapy as is usually practiced in clinics
Other Name: TAU

Detailed Description:

Children experiencing traumas, such as sexual abuse, physical abuse, domestic violence, serious accidents, or natural disasters, may develop severe health problems.

This study will examine the short and long-term effects of trauma-focused cognitive-behavioural therapy on children exposed to serious trauma, and moderating factors of treatment outcome.

The study will use a random control design, and will be implemented in regular clinical practice in Norway.

More knowledge within this field is important for practitioners as well as policy makers in planning interventions and therapy for children and their caregivers.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between the age of 10-18
  • referred to a guidance clinic
  • who have experienced trauma
  • present with PTSD reactions
  • participants and the primary caretaker must be able to speak Norwegian.

Exclusion Criteria:

  • Severe psychosis
  • Severe mental retardation.
  • The youth must not have had severe conduct disorders previous to the trauma experience
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635752


Locations
Norway
Norwegian center for violence and traumatic stress studies
Oslo, Norway
Sponsors and Collaborators
Norwegian Center for Violence and Traumatic Stress Studies
Norway: Directorate for Health and Social Affairs
Investigators
Principal Investigator: Tine K Jensen, PhD Norwegian Centre for Violence and Traumatic Stress Studies
  More Information

Publications:
Holt, T., Cohen, J. A., Mannarino, A., & Jensen, T. K. (2014). Parental Emotional Response to Children's Traumas. Journal of Aggression, Maltreatment & Trauma. 23(10), 1057-1071. doi: 10.1080/10926771.2014.953717

Responsible Party: Tine K. Jensen, Professor, Norwegian Center for Violence and Traumatic Stress Studies
ClinicalTrials.gov Identifier: NCT00635752     History of Changes
Other Study ID Numbers: s-07442a(REK)
First Submitted: March 11, 2008
First Posted: March 14, 2008
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Tine K. Jensen, Norwegian Center for Violence and Traumatic Stress Studies:
TF-CBT
Effectiveness study
Trauma
Therapy

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders